MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION UNI-VENT, MODEL 731; VENTILATOR

Model Number 799-EMVP-04-05

Device Problems Communication or Transmission Problem (2896); Failure of Device to Self-Test (2937)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Complainant alleged that during biomed testing, the device displayed "self check" and "internal comm failure" error messages.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.A review of the device log indicates the user corrupted the calibration tables.The vent module serial numbers were written to the device to resolve the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

Manufacturer Narrative

This supplemental medwatch report updates information submitted in the previous medwatch report.Adding justification per your request for the reason why d4 primary udi was no_udi.The device in the report is not distributed domestically and, therefore is not required to have an associated udi-di in the report.Additionally, when the device was manufactured and distributed into the intended geography, there was no existing udi-di regulation for the geography.

• Brand Name: UNI-VENT, MODEL 731
• Type of Device: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18031206
• MDR Text Key: 326867898
• Report Number: 1220908-2023-04242
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K111473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 799-EMVP-04-05
• Device Catalogue Number: 799-EMVP-04-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1